PMA P060028S004

Device: MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S004
Product code: FTR
Decision date: 2014-12-16
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: CHANGE TO AUTOMATE THE MANUAL SECONDARY PACKAGING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IM LANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.

Current openFDA PMA Record#

Device: MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S004
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2014-12-16
Decision code: OK30
Date received: 2014-12-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO AUTOMATE THE MANUAL SECONDARY PACKAGING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IM LANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.